PETITIONER RICETEC
`DEMONSTRATIVE EXHIBITS
`
`Oral Arguments
`December 13, 2022
`
`RiceTec, Inc. v. BASF
`PGR2021-00113
`PGR2021-00114
`U.S. Patent No. 11,096,345
`U.S. Patent No. 11,096,346
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`Unless specifically indicated,
`cites in the slides are to the
`Record in PGR2021-00113
`
`

`

`GROUNDS FOR CANCELLATION
`
`Paper 2 at 8-9.
`
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`2
`
`

`

`PATENT OWNER’S RESPONSE
`
`Patent Owner failed to substantively
`address any of these grounds in their
`responsive papers, which include:
`
`• PO’s Preliminary Response (Paper 15)
`• PO’s Sur-Reply to Preliminary Response (Paper 20)
`• Burgos Declaration in support of PO’s Preliminary Response (Ex. 2003)
`• PO’s Response to Petition (Paper 24)
`• Somers’ Declaration in support of PO’s Response to Petition (Ex. 2036)
`• PO’s Sur-Reply to Petition (Paper 29).
`
`Paper 27 at 1-2, 23-26.
`
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`3
`
`

`

`Instead, PO chose to focus on the Grounds for Standing,
`namely, that the ‘345 patent (or ‘346 patent) is not PGR eligible
`because it is entitled to the filing date of its parent CIP Mankin
`line.
`
`• PO did not address any grounds of anticipation and obviousness, but only that if the
`‘345 patent is entitled to its parent application date, the references would no longer
`be prior art.
`• PO did not address the actual written description and enablement of the claims, but
`only that if the claims are adequately described by the parent applications, the
`claims would also be adequately described by their actual application because they
`contained more disclosure than its parents.
`• PO did not address enablement of the claims for either the parent applications or
`the actual application.
`
`Paper 24 at 1-7, Paper 27 at 1-2, 23-26.
`
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`4
`
`

`

`SINGLE ISSUE FOR THE PTAB TO DECIDE
`
`A priority issue:
`
`Are the claims of the ‘345 patent (or ‘346 patent)
`adequately described and enabled by the Mankin
`CIP parent application?
`
`Paper 27 at 1-2, 22-23.
`
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`5
`
`

`

`GROUNDS FOR STANDING
`Thus, “a patent that issues from an application filed after
`March 16, 2013, that claims priority to an application filed
`before March 16, 2013, is available for post-grant review
`‘if the patent contains…at least one claim that was not
`disclosed in compliance with the written description and
`enablement requirements of § 112(a) in the earlier
`application for which the benefit of an earlier filing date
`prior to March 16, 2013 was sought.” U.S. Endodontics,
`LLC v. Gold Standard Instruments, LLC, PGR2015-00019,
`Paper 17, at 8 (PTAB January 20, 2016) (emphasis added).
`
`Paper 2 at 6-7.
`
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`6
`
`

`

`GROUNDS FOR STANDING
`
`Petitioner’s burden to show that ‘345 patent (or
`‘346 patent) was not entitled to:
`
`An effective filing date of PCT/US2012/064831
`(dated November 13, 2012 (“Neuteboom PCT”);
`
`An effective filing date of PCT/US2010/047571
`(dated September 1, 2010) (national entry of the
`U.S. Application 13/393,780 was dated March 1,
`2012) (collectively “Mankin PCT” or “’780
`application”).
`
`Paper 2 at 29-32.
`
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`7
`
`

`

`‘345 Patent Claim 1
`
`A method for treating rice, comprising:
`
`(A) providing
`
`(1) a domestic rice crop plant grown from seed, the domestic rice crop plant
`
`(a) comprising and expressing an endogenous non-transfected mutant ACCase nucleic acid whose sequence encodes a multi-
`functional, plastidic ACCase containing a mutation selected from the group consisting of I1781L (Am), G2096S (Am), and W2027C (Am); and
`
`(b) possessing a phenotype of tolerance to quizalofop or an ester thereof, fluazifop or an ester thereof, clodinafop, clodinafop-
`propargyl, or diclofop or diclofop methyl, wherein said plant exhibits less than 10% herbicide injury to a field application of at least 70 g AI/ha to 140 g
`AI/Ha of clodinafop-propargyl, at least 11 g AI/Ha to 34 g AI/Ha of clodinafop, at least 56 g AI/Ha to 140 g AI/Ha of fluazifop or an ester thereof, at least 14 g
`AI/Ha to 140 g AI/Ha of quizalofop or an ester thereof, or at least 226 g AI/Ha to 540 g AI/Ha of diclofop or diclofop-methyl; and
`
`(2) at least one ACCase-inhibiting aryloxyphenoxypropanoate herbicide comprising quizalofop or an ester thereof, fluazifop or an ester thereof,
`clodinafop, clodinafop-propargyl, diclofop, or diclofop-methyl;
`
`(B) applying an effective amount (measured in grams of active ingredient per hectare (g AI/Ha)) of the at least one aryloxyphenoxypropanoate herbicide to
`the domestic rice crop plant, post-emergence, thereby creating a treated rice plant; and
`
`(C) growing the treated rice plant;
`
`wherein the effective amount of the at least one ACCase-inhibiting aryloxyphenoxy-propanoate herbicide is at least 70 g AI/Ha to 140 g AI/Ha of
`clodinafop-propargyl, at least 11 g AI/Ha to 34 g AI/Ha of clodinafop, at least 56 g AI/Ha to 140 g AI/Ha of fluazifop or an ester thereof, at least 14 g AI/Ha
`to 140 g AI/Ha of quizalofop or an ester thereof, or at least 226 g AI/Ha to 540 g AI/Ha of diclofop or diclofop-methyl.
`
`Paper 2, claim 1, Ex. 1001.
`
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`8
`
`

`

`‘346 Patent Claim 1
`
`A method for treating rice, comprising:
`
`(i) providing at least one ACCase-inhibiting aryloxyphenoxypropanoate herbicide selected from the group consisting of quizalofop,
`an ester of quizalofop, an enantiomer of quizalofop, and an agriculturally acceptable salt of quizalofop;
`
`(ii) providing a domestic rice crop plant grown from seed, the domestic rice crop plant comprising and expressing an endogenous
`non-transfected mutant ACCase nucleic acid whose sequence encodes a multi-functional, plastidic ACCase containing a mutation selected
`from the group consisting of I1781L (Am), G2096S (Am), and W2027C (Am) that causes the ACCase to be tolerant to the herbicide, the
`nucleic acid thereby providing to the plant tolerance to the aryloxyphenoxypropanoate herbicide;
`
`(iii) applying an effective amount (measured in grams of active ingredient per hectare (g AI/Ha)) of the at least one
`aryloxyphenoxypropanoate herbicide to the domestic rice crop plant, post-emergence; thereby creating a treated rice plant; and
`
`(iv) growing the treated rice plant,
`
`wherein the effective amount of the at least one ACCase-inhibiting aryloxyphenoxypropanoate herbicide is 14 g AI/Ha to 40 g AI/Ha of
`quizalofop or an ester of quizalofop, or an amount equivalent to 14 g AI/Ha to 40 g AI/Ha of quizalofop or an ester of quizalofop, and wherein
`the effective amount of the aryloxyphenoxypropanoate herbicide causes less than 10% injury to the rice plant in field applications, wherein
`the injury to the rice plant is evaluated 2-3 weeks after herbicide treatmen
`
`Paper 2, claim 1, Ex. 1001.
`
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`9
`
`

`

`CLAIM CONSTRUCTION
`
`Claim term
`“endogenous non-
`transfected mutant”
`
`“effective amount”
`
`Claim Construction
`Nucleic acid is endogenous to the
`respective cell, seed, plant, or plant part
`and by “non-transfected,” it contains a
`mutation that was produced randomly by a
`technique involving no step of introducing
`exogenous material into the plant cell or
`plant, i.e., no recombinant DNA technology.
`The amounts of FOPs herbicide specifically
`listed in the claims such that it causes less
`than 10% injury to the rice plant.
`
`Disputed?
`Not disputed
`
`Disputed by PO.
`
`Institution Decision stated that “we
`consider the ‘less than 10% injury’
`together with the effective amounts
`of herbicides to constitute the
`‘effective amount’ limitations.” See
`Institution Decision at 15, 18
`
`Paper 21 at 15, 18.
`
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`10
`
`

`

`•
`
`INSTITUTION DECISION
`• Challenged Claims are PGR eligible.
`• No written description support from Mankin PCT line – focused on the fact that Mankin PCT
`did not adequately describe “effective amount” limitation of claims
`• No written description support from the Neuteboom PCT line – also focused on the fact that
`Neuteboom PCT did not adequately describe “effective amount” limitation of claims.
`“Because we find each of the challenged claims lacks written description support in any parent
`application filed before March 15, 2013, we need not address whether the parent applications
`also enable the claims to determine that the ‘345 patent is eligible for post-grant review.” Id.
`at 22.
`• Petitioner has not shown on the preliminary record that it is more likely than not that the ‘345
`patent (or ‘346 patent) fails to provide an adequate written description.
`• Petitioner has not established on the preliminary record that it is more likely than not that a POSA
`would not have been able to practice the claimed invention without undue experimentation
`• Petitioner has shown on the preliminary record t is more likely than not that the Challenged Claims
`are anticipated or obvious over the prior art of record.
`Paper 21.
`
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`11
`
`

`

`Patent Owner’s Burden of Production
`
`“In this case, Dynamic, as the petitioner, had the burden of persuasion to prove
`unpatentability by a preponderance of the evidence, and this burden never
`shifted. Dynamic also had the initial burden of production, and it satisfied that
`burden by arguing that Raymond anticipated the asserted claims of the '196
`patent under § 102(e)(2).
`
`The burden of production then shifted to National Graphics to argue or produce
`evidence that either Raymond does not actually anticipate, or, as was argued
`in this case, that Raymond is not prior art because the asserted claims in the
`'196 patent are entitled to the benefit of a filing date (constructive or otherwise)
`prior to the filing date of Raymond.”
`
`See Dynamic Drinkware, LLC v. Nat’l Graphics, Inc., 800 F.3d 1375 1379-1380 (Fed.
`Cir. 2015).
`
`Paper 27 at 23-24.
`
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`12
`
`

`

`Patent Owner Failed To Meet Its Burden of Production
`
`Petitioner RiceTec has the ultimate burden of proof to prove unpatentability of the challenged claims – this
`never changes.
`
`But, Petitioner RiceTec also met its burden of proving unpatentability of the challenged claims when it
`showed a prima facie case of anticipation and obviousness based on the Grounds 3-5 (Hinga references)
`
`That burden of production then shifted to PO BASF to either prove that:
`
`The prior art did not anticipate or render the challenged claims
`obvious; or
`
`PO did not address this on the record
`
`The cited references (i.e., Hinga references) are not prior art
`because the challenged claims are entitled to an earlier filing date
`of their parent applications by showing that the parent
`applications both adequately described and enabled the
`challenged claims.
`
`PO did not meet this burden; at best, PO
`only addressed priority through written
`description (not enablement), and for
`written description, PO’s priority
`arguments are defective for reasons set
`forth below.
`
`Paper 27 at 23-24.
`
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`13
`
`

`

`Challenged Claims Are Not Described And Enabled
`By The Mankin CIP Parent – Preliminary Points
`
`• Claims issued from a CIP application from the Mankin Application – new
`matter was added to the application which resulted in the claims
`• During prosecution of the claims, the Office determined at least twice
`that the application was being examined “under the first inventor to file
`provisions of the AIA.” In other words, the Office determined that the
`claims were not afforded priority to the pre-March 16, 2013 AIA date of
`the Mankin CIP parent.
`• PTAB in its Decisions Granting Institution ruled that the claims were PGR
`eligible, i.e., that the claims were not afforded priority to the pre-March
`16, 2013 AIA date of the Mankin CIP parent.
`
`Paper 2 at 13-19, 47-49, Paper 21, Paper 27 at 1-3.
`
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`14
`
`

`

`Challenged Claims Are Not Described And
`Enabled By The Mankin CIP Parent
`All of the claims are to the method of treating rice:
`
`•
`
`• where the rice crop comprises the endogenous non-transfected
`random G2096S ACCase mutation
`causing the rice crop to be tolerant to the various claimed FOPs, i.e.,
`quizalofop, at the various claimed effective amounts, i.e., 14-140 g
`AI/Ha.
`• where tolerance is measure by the rice crop exhibiting less than 10%
`injury.
`
`Paper 2.
`
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`15
`
`

`

`Mankin CIP Parent Merely Lists The G2096S Mutation Among
`Hundreds Of Other Potential ACCase Mutations
`
`The present invention relates to herbicide-tolerant plants and methods of producing and treating herbicide-tolerant plants. In one embodiment, the present invention provides a
`rice plant tolerant to at least one herbicide that inhibits acetyl-Coenzyme A carboxylase activity at levels of herbicide that would normally inhibit the growth of a rice plant.
`Typically, an herbicide-tolerant rice plant of the invention expresses an acetyl-Coenzyme A carboxylase (ACCase) in which the amino acid sequence differs from an amino
`acid sequence of an acetyl-Coenzyme A carboxylase of a wild-type rice plant. By convention, mutations within monocot ACCase amino acid residues are typically referred to
`in reference to their position in the Alopecurus myosuroides (blackgrass) plastidic monomeric ACCase sequence (Genbank CAC84161.1) and denoted with an (Am). Examples
`of amino acid positions at which an acetyl-Coenzyme A carboxylase of an herbicide-tolerant plant of the invention differs from the acetyl-Coenzyme A carboxylase of the
`corresponding wild-type plant include, but are not limited to, one or more of the following positions: 1,781(Am), 1,785(Am), 1,786(Am), 1,811(Am), 1,824(Am), 1,864(Am),
`1,999(Am), 2,027(Am), 2,039(Am), 2,041(Am), 2,049(Am), 2,059(Am), 2,074(Am), 2,075(Am), 2,078(Am), 2,079(Am), 2,080(Am), 2,081(Am), 2,088(Am), 2,095(Am),
`2,096(Am), or 2,098(Am). Examples of differences at these amino acid positions include, but are not limited to, one or more of the following: the amino acid at position
`1,781(Am) is other than isoleucine; the amino acid at position 1,785(Am) is other than alanine; the amino acid at position 1,786(Am) is other than alanine; the amino acid at
`position 1,811(Am) is other than isoleucine; the amino acid position 1,824(Am) is other than glutamine; the amino acid position 1,864(Am) is other than valine; the amino acid
`at position 1,999(Am) is other than tryptophan; the amino acid at position 2,027(Am) is other than tryptophan; the amino acid position 2,039(Am) is other than glutamic acid;
`the amino acid at position 2,041(Am) is other than isoleucine; the amino acid at position 2,049(Am) is other than valine; the amino acid position 2,059(Am) is other than an
`alanine; the amino acid at position 2,074(Am) is other than tryptophan; the amino acid at position 2,075(Am) is other than valine; the amino acid at position 2,078(Am) is
`other than aspartate; the amino acid position at position 2,079(Am) is other than serine; the amino acid at position 2,080(Am) is other than lysine; the amino acid position at
`position 2,081(Am) is other than isoleucine; the amino acid at position 2,088(Am) is other than cysteine; the amino acid at position 2,095(Am) is other than lysine; the amino
`acid at position 2,096(Am) is other than glycine; or the amino acid at position 2,098(Am) is other than valine. In some embodiments, the present invention provides a rice
`plant expressing an acetyl-Coenzyme A carboxylase enzyme comprising an amino acid sequence that comprises one or more of the following: the amino acid at position
`1,781(Am) is leucine, threonine, valine, or alanine; the amino acid at position 1,785(Am) is glycine; the amino acid at position 1,786(Am) is proline; the amino acid at position
`1,811(Am) is asparagine; the amino acid at position 1,824(Am) is proline; the amino acid at position 1,864(Am) is phenylalanine; the amino acid at position 1,999(Am) is
`cysteine or glycine; the amino acid at position 2,027(Am) is cysteine; the amino acid at position 2,039(Am) is glycine; the amino acid at position 2,041(Am) is asparagine; the
`amino acid at position 2049(Am) is phenylalanine; the amino acid at position 2,059(Am) is valine; the amino acid at position 2,074(Am) is leucine; the amino acid at position
`2,075(Am) is leucine, isoleucine or methionine; the amino acid at position 2,078(Am) is glycine, or threonine; the amino acid at position 2,079(Am) is phenylalnine; the amino
`acid at position 2,080(Am) is glutamic acid; the amino acid at position 2,080(Am) is deleted; the amino acid at position 2,081(Am) is deleted; the amino acid at position
`2,088(Am) is arginine, or tryptophan; the amino acid at position 2,095(Am) is glutamic acid; the amino acid at position 2,096(Am) is alanine, or serine; or the amino acid at
`position 2,098(Am) is alanine, glycine, proline, histidine, or serine.
`
`Paper 2 at 34-36, Paper 27 at 5-7, Ex. 1002 at 31-34, Ex. 2034, [0007].
`
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`16
`
`

`

`Mankin PCT (’780 Appl’) Merely Lists The G2096S Mutation
`Among Hundreds Of Other Potential ACCase Mutations
`
`OVER 90 PARAGRAPHS OF REPEATED LISTINGS
`
`Paper 2 at 34-36, Paper 27 at 5-7, Exs. 2034, ¶¶ 7-10, 18, 23, 27, 32-34, 127-210
`
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`17
`
`

`

`Mankin CIP Parent Never Distinguishes The G2096S
`Mutation From The Other Hundreds Of Mutations
`
`• Never distinguishes this mutation over the other ACCase
`mutations as to tolerance levels against different herbicides;
`• Never shows how this mutation could be randomly mutated and
`selected over any other mutations with selection conditions that
`would lead the skilled worker to arrive at this mutation;
`• Never shows any data regarding significance of this mutation
`over other mutations
`• Never explains why this mutation was chosen as a potential
`candidate for herbicide tolerant rice over other mutations.
`
`Paper 2 at 34-36, Paper 27 at 5-7.
`
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`18
`
`

`

`Mankin CIP Parent Never Distinguishes The G2096S Mutation From The Other
`Hundreds Of Mutations – Admissions by PO’s Expert Dr. Somers
`
`Q Now, we've gone through a bunch of different listings within the particular PCT
`application. Now, is there anywhere in this PCT application where the G-2096-S
`mutation and ACCase is distinguished among the other more than 100 different
`mutations that are contemplating?
`A I think it's mentioned repeatedly along with 2027-C and 1781-L.
`Q When you say that it's mentioned repeatedly, but is that repeated mentioning in
`distinction to the other mutations that are identified at the other locations?
`[objection]
`A They're all mentioned. There's no question.
`Q Not only are they mentioned as locations at 20 -- at the 22 position, but
`multitudes of mutations at each of the 22 locations; right?
`A Correct.
`[objection]
`Q And there's nothing in the PCT application which distinguishes the G-2096-S
`mutation from any of these other listed contemplated mutations; right?
`[objection]
`A. I -- well, I -- in the PCT, no. Nope.
`
`Paper 27 at 5-6, Ex. 1052 at 109.
`
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`19
`
`

`

`Dr. Shaner’s Opinions Regarding Priority To The
`Mankin CIP Parent
`Dr. Shaner concludes that these repeated listings do not convey to one of skill in
`the art that the inventors had possession of rice plants from seed that contains
`the G2096S mutation such that the rice plant is tolerant to the claimed FOPs
`(including quizalofop) at the claimed levels to result in less than 10% injury to the
`rice.
`
`Figures 18 and 19 of the Mankin CIP Parent are just the deduced amino acid
`sequences of the generic listings against the known protein sequence of ACCase –
`all of which was known in the prior art.
`
`Dr. Shaner – Petitioner’s Expert
`
`All the applicants did was scour the prior art for ACCase mutation in other plant
`species, like weeds, and listed them in the specification while showing only 1
`example of herbicide tolerant rice (I1781L) with deposited seeds from the ATCC.
`
`But this experiment was with the 1781 mutation (not 2096) and shown to be only
`resistant to cyxcloxydim, a whole different family of herbicides from the claimed
`FOPs herbicide, and at levels exceeding the less than 10% injury rate of the rice.
`
`Paper 2 at 34-37, Ex. 27 at 7-11, Ex. 1002 at 31-44.
`
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`20
`
`

`

`Dr. Shaner Concluded That The Challenged Claims Are
`Inherently Unpredictable
`Dr. Shaner concluded that the Challenged Claims are inherently unpredictable because they claim
`random and spontaneous mutations, which cannot be predicted.
`
`Dr. Shaner –
`Petitioner’s Expert
`
`“I emphasized earlier that the Challenged Claims require that the G2096S ACCase mutation be
`‘endogenous’ and ‘non-transfected.’ In other words, the claimed G2096S mutation must be the result
`of a random and spontaneous mutation and not through techniques involving human modifications,
`such as recombinant DNA technology. This is crucial, since merely listing the G2096S ACCase
`mutation among dozens of other mutations and referencing herbicide tolerant plants that were
`generated from tissue with a spontaneous mutation at another location within the ACCase enzyme,
`i.e., I1781L, does not demonstrate that the inventors were in possession of rice plants that
`contained the endogenous non-transfected G2096A ACCase mutation.” Shaner Decl. ¶75.
`
`Even PO Expert Somers agreed that the random mutations of the claims made them unpredictable.
`
`“Because there's enough sequence polymorphism among the genomes of these different weeds and species, it's
`difficult -- it's -- it’s difficult to know if such a selected mutation would both, one, confer the tolerance and also not
`debilitate the enzyme in any way because that’s a little bit of the -- the unknown, the trick of isolating such a mutant
`that would be – confer adequate tolerance and not impact the plant performance.” Tr. 35
`
`Paper 2, Paper 27, Exs. 1002, 1052.
`
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`21
`
`

`

`Dr. Shaner’s Opinions Regarding Priority To The
`Mankin CIP Parent – No “A Priori Approach”
`Because of the “random” and “unpredictable” nature of the claims, which preclude
`the use of human intervention in obtaining the random mutation, the inventors never
`had an “a priori” approach to selecting any particular ACCase mutation.
`
`Inventors relied upon random “somaclonal” variations of the tissue culture and
`“chemical mutagens” to induce a random mutation among millions of cell – random
`event over random event (Example 1).
`
`Dr. Shaner – Petitioner’s Expert
`
`Inventors then subjected the tissue culture with different kinds of DIMs herbicides
`(not the claimed FOPs). Application says mutant plant was the results step-wise
`selection using cycloxydim. (Example 2, Figure 2).
`
`Surviving rice tissue was regenerated into plants that could set seed (fertile). (Example 3) This was not routine, because
`mutations from somaclonal variation and chemical mutagens can drastically affect health fertility of rice plant.
`
`Only after all of this testing and selection were the surviving plants sequenced – which were found to have the I1781L
`ACCase mutation. This was never pre-selected – it was the RESULT of the experiments not possession of a
`preconceived idea.
`
`Paper 2 at 12-13, 36-38, Ex. 1002 at 31-44.
`
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`22
`
`

`

`IN ORDER TO RANDOMLY OBTAIN EVEN JUST THE
`I1781L MUTATION, PO HAD TO GROW AND SCREEN
`MILLIONS OF RICE CELLS
`
`Paper 27 at 8-11, Ex. 2034.
`
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`23
`
`

`

`Dr. Shaner’s Opinions Regarding Priority To The
`Mankin CIP Parent – No “A Priori Approach
`“This experimental work within the ’780 application shows
`that the rice calli and regenerated plants were not selected
`based on a preconceived belief that a particular ACCase
`gene mutation, such as at I1781L or G2096S, would create
`fertile herbicide tolerant rice plants. Instead, the plants
`and plant tissue were selected based on their ability to
`survive exposure to the herbicides and were later
`sequenced to determine if they had ACCase mutations.
`The mutations themselves were completely random, and
`the fact that the plants contained a mutation at a particular
`location within the ACCase gene, i.e., I1781L, was the result
`of this spontaneous event.” (Para. 89).
`
`Dr. Shaner – Petitioner’s Expert
`
`Paper 2 at 38, Ex. 1002 at 14-15, 36-45.
`
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`24
`
`

`

`Dr. Shaner Concluded That The Mankin CIP Parent Application Taught
`Away From Obtaining A G2096S Herbicide Tolerant Rice Plant
`
`Dr. Shaner
`
`Paper 2 at 38-40, Paper 27 at 10, Exs. 1002 at 14-15, 43-44, 2034.
`
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`25
`
`

`

`Dr. Shaner Concluded That The Mankin CIP Parent Application Taught
`Away From Obtaining A G2096S Herbicide Tolerant Rice Plant
`
`...
`
`Dr. Shaner
`
`Paper 2 at 38-40, Paper 27 at 10, Exs. 1002 at 14-15, 43-44, 2034.
`
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`26
`
`

`

`Dr. Shaner Concluded That The Mankin CIP Parent Application Taught Away
`From Obtaining A G2096S Herbicide Tolerant Rice Plant
`
`Only reasonable conclusion is that Haloxyfop was not used to select for any of the mutant rice
`plants found to be herbicide tolerant – Only DIMs were used
`
`As of the time of the filing of the Mankin CIP Parent, it was known that DIMS could not select for
`the ACCase mutation at 2096, since the 2096 mutation is sensitive to DIMS, i.e., DIMS would kill
`rice tissue and plants with the 2096 mutation.
`
`Dr. Shaner
`Patent Office Agreed
`“It was well known at the time of
`the filing that the G2096A
`substitution conferred little or no
`tolerance to cyclohexanedione
`[DIMs] herbicides.” Application
`No. 15/396,004 (Ex. 1023 part 2
`at 598).
`
`As a result, the Mankin CIP Parent teaches against creating the claimed FOP resistant ACCase
`tolerant rice
`Even PO BASF’s Expert – Somers admitted this
`Q Do you think one looking at Table 4 or anything else in the Mankin PCT application
`would be able to predict these mutation frequencies with respect to the 2096
`mutation?
`[Objection]
`THE WITNESS: In rice -- in rice tissue cultures under the selection system, I don't – I
`don't think a POSA would -- well, I think it gives you a guideline to predict how much
`work you'd have to do to do it, but I don't think a POSA would attempt at their first
`attempt to use a Dim for selection of 2096. (Tr. 92).
`
`Paper 2 at 38-40, Paper 27 at 10,
`Exs. 1002 at 14-15, 43-44, 2034, 1023, 1052.
`
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`27
`
`

`

`Dr. Shaner’s Opinions Were Unimpeached During Deposition
`The only evidence of record PO cites in response to Dr. Shaner’s
`Opinion That DIMs could not select for the 2096 ACCase mutation is
`Figure 27 of Neuteboom.
`
`Neuteboom was filed after the Mankin CIP parent and not available as
`prior art to the POSA.
`
`PO stated in its Opposition that it no longer relied upon Neuteboom
`as support for priority (fn. 3)
`
`Figure 27 no where near shows written description or enablement of
`the claims as shown in Shaner’s chart.
`
`PO’s expert Somers agreed with Shaner at deposition:
`A Well, first, it's after the 2010 period, and secondly, it's -- it's not a
`direct expression of this allele in rice. That's what I mean. So, it’s
`supportive, but it doesn't directly tell you that this is going to
`result in a herbicide tolerant phenotype.
`Q Herbicide tolerant what?
`A Phenotype in rice.
`Q As claimed in the --
`A Right.
`Q -- 345, 346 patent?
`A Right. (Tr. 197)
`Paper 2 at 38-40, Paper 24, Paper 27 at 10, Exs. 1002 at 14-15, 43-44,
`2034, 1023, 1052.
`
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`28
`
`

`

`Inventors Never Deposited Any Rice Seeds Containing The G2096S
`ACCase Mutation
`Inventors only deposited seeds with the I1781L ACCase mutation, even though Challenged Claims cover
`G2096S and W2027C ACCase mutated rice seeds.
`
`Written Description - In cases like this involving biological materials, where the subject matter of the
`invention is highly unpredictable and not routinely reproducible, the failure to deposit these materials
`dictates against a finding of an adequate written description.
`
`See Ex Parte Maizel, 27 USPQ2d 1662, 1992 WL 519152, *5 (BPAI 1992) (ATCC deposit to cell line containing
`only one of the two plasmids said to contain DNA coding for protein lacked written description to claims that
`broadly covered biologically equivalent proteins);
`
`Ex Parte Iwakura et al., Appeal 2019-002524, 2019 WL 6208493, *4 (PTAB 2019) (claims to antibodies found
`to lack written description when no structure was provided and no deposit was made);
`
`Enzo Biochem, Inc. v. Gen-Probe Inc., 285 F.3d 1013, 1021-22 (Fed. Cir. 2002) (written description of functional
`claims to all DNA that hybridize to a particular bacteria was not satisfied where deposit was made of only
`three probes).
`
`Paper 2 at 36-37.
`
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`29
`
`

`

`Inventors Never Deposited Any Rice Seeds Containing The G2096S
`ACCase Mutation
`Enablement - The Office has routinely held claims invalid for lack of enablement where, as here, the claims relied upon
`random mutagenesis to capture broad plant phenotypes and the applicant failed to deposit biological materials
`commensurate with the full scope of the claims.
`
`Ex Parte Wong, Appeal 93-3238, 1994 WL 1709498, *8-9 (BPAI 1994) (noting that the effect of mutagenesis on the oleic
`acid content of rapeseeds is “completely unpredictable,” the Board found that deposits to seeds showing only 81.9% oleic
`acid was insufficient to enable the full scope of the claims, which read on rapeseeds having an oleic acid content from
`80% - 100%);
`
`Ex Parte Hardison, Appeal 2013-010623, 2016 WL 4194382, *11-12 (PTAB 2016) (finding claims to hybrid plants invalid for
`lack of enablement where the specification only showed deposits to four such hybrids and given the high unpredictability
`of the art of trying to reproduce plant traits);
`
`Ex Parte Pod-Ners, L.L.C., Appeal 2007-3938, 2008 WL 1901980, *11 (BPAI 2008) (finding claims to seeds of Phaselous
`vulgaris with a uniform yellow coat invalid for lack of enablement since the seeds on deposit were too phenotypically
`varied in population and it would require undue trial and error to screen plants for the claimed characteristics);
`
`Ex Parte C, 27 U.S.P.Q.2d 1492, 1992 WL 515817 (BPAI 1992) (claims to a particular variety of plant would not be enabled
`without actually depositing seeds from that variety since “even an exacting” description for crossbreeding and selection
`would only arrive at a substantially similar but different variety).
`
`Paper 2 at 60-63.
`
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`30
`
`

`

`PO’s Counter-Arguments Rebutted By The Record
`
`PO’s Counter-Argument
`The listings of ACCase mutations in the
`Mankin CIP parent are not a “Laundry List” of
`generic mutations where the G2096S is just
`buried.
`
`The Evidence on Record
`During prosecution of the ’780 application
`(same as the Mankin CIP parent), the Office
`rejected claims to rice containing the I1781A,
`I1781V, or A1781T mutations for lack of
`written description because the “lists of
`numerous of possible embodiments, would
`not reasonably lead one skilled in the art” to
`the invention are just a “laundry list.” (Ex.
`1017 at 1382-83).
`
`Clearly, if the “laundry list” of mutations cannot support a written description herbicide tolerant rice
`with mutations at the I1781A, I1781V, or A1781T, when the specification even has an example to
`I1781L rice plants, then it cannot support a written description to a rice plant with a G2096S mutation,
`which is at a completely different position from the 1781.
`
`Paper 2 at 17-19, Paper 27 at 13.
`
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`31
`
`

`

`PO’s Counter-Arguments Rebutted By The Record
`
`PO’s Counter-Argument
`The G2096S mutation is identified as a
`“preferred embodiment” and a “most
`preferred embodiment” in the specification.
`
`The Evidence on Record
`There are hundreds of other ACCase
`mutations “preferred embodiments” listed in
`the specification, and even dozens of other
`“most preferred embodiments”
`
`•
`
`•
`
`There are literally hundreds of ACCase mutations other than the G2096S mutation
`listed as “preferred embodiments in the specification, spanning dozens of paragraphs
`within the specification. See 2024, paragraphs [0129] – [0153], [0159] – [0199], [0208]
`– [0210].
`
`In fact, all of the ACCase mutations listed at a particular location in the specification
`(22 in total, amounting to hundreds of variations) are listed as “preferred
`embodiments.”
`
`Paper 2 at 34-35, Paper 27 at 5-7, 27, Ex. 1052.
`
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`32
`
`

`

`PO’s Counter-Arguments Rebutted By The Record
`
`“most preferred” mutations
`“In a most preferred embodiment the acetyl-Coenzyme A carboxylase of an herbicide-tolerant
`plant of the